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Filing a DMF for Hard Gelatin Capsule Shells with the U.S. FDA

Filing a drug master file (DMF) for Hard Gelatin Capsule Shells can be a useful mechanism to market your Hard Gelatin Capsule Shells to the U.S. Drug Industry. Typical Hard Gelatin Capsule Shells producers who have filed a DMF for Hard Gelatin Capsule Shells include:

  - Associated Capsules Group

Registrar Corp can help you to properly prepare and submit your Hard Gelatin Capsule Shells DMF to FDA.

As your Agent, Registrar Corp will perform the following administrative functions:

  - Format, assemble and deliver your Hard Gelatin Capsule Shells DMF to FDA
  - Submit letters of authorization regarding your Hard Gelatin Capsule Shells to FDA
 - Provide changes, additions and maintenance of your Hard Gelatin Capsule Shells DMF
  - Respond to issues relating to ownership of your Hard Gelatin Capsule Shells DMF
  - Assist with submission of responses to FDA concerning your Hard Gelatin Capsule Shells DMF
  - Perform any required annual updates for your Hard Gelatin Capsule Shells DMF

For more information about filing a DMF for Hard Gelatin Capsule Shells, simply click below:




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U.S. FDA Regulations:

U.S. FDA DMF Regulation: 21 C.F.R. Section 314.420


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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